Trial Outcomes & Findings for A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis (NCT NCT02387801)
NCT ID: NCT02387801
Last Updated: 2019-09-18
Results Overview
The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.
COMPLETED
PHASE3
12 participants
Baseline through Week 12
2019-09-18
Participant Flow
Induction Dosing Period (Weeks 0 up to 12), Maintenance Dosing Period (Weeks 12 up to 48), Minimum Post Treatment Follow-Up Period up to 12 weeks after last visit.
Participants were randomized to ixekizumab (ixe) 80 mg Q2W or Q4W during the Induction Dosing Period from Week 0 to Week 12. Participants received ixe Q4W in the Maintenance Dosing Period from Week 12 to Week 48, and then to the Post Follow up Treatment Period for at least 12 weeks.
Participant milestones
| Measure |
Ixekizumab Q2W
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
|
Ixekizumab Q4W
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44.
|
|---|---|---|
|
Induction Dosing Period
STARTED
|
6
|
6
|
|
Induction Dosing Period
COMPLETED
|
6
|
6
|
|
Induction Dosing Period
NOT COMPLETED
|
0
|
0
|
|
Maintenance Dosing Period
STARTED
|
0
|
12
|
|
Maintenance Dosing Period
COMPLETED
|
0
|
12
|
|
Maintenance Dosing Period
NOT COMPLETED
|
0
|
0
|
|
Post-Treatment Follow-up
STARTED
|
0
|
12
|
|
Post-Treatment Follow-up
COMPLETED
|
0
|
12
|
|
Post-Treatment Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis
Baseline characteristics by cohort
| Measure |
Ixekizumab Q2W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
|
Ixekizumab Q4W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 12.54 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 7.39 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 12.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 12Population: All randomized participants.
The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.
Outcome measures
| Measure |
Ixekizumab Q2W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
|
Ixekizumab Q4W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
|
|---|---|---|
|
Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score
|
5.0 Days
Interval 2.0 to 5.0
|
6.0 Days
Interval 4.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants.
The Itch NRS is a patient-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Least Square Means (LS means) are from analysis of mixed-effects model for repeated measures (MMRM) and model includes treatment group, baseline value and timepoint.
Outcome measures
| Measure |
Ixekizumab Q2W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
|
Ixekizumab Q4W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
|
|---|---|---|
|
Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score
|
-6.2 units on a scale
Standard Error 0.53
|
-6.6 units on a scale
Standard Error 0.55
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants.
The DLQI is a simple, patient-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). LS means are from analysis of MMRM and model includes treatment group, baseline value and timepoint.
Outcome measures
| Measure |
Ixekizumab Q2W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
|
Ixekizumab Q4W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
|
|---|---|---|
|
Mean Change From Baseline on the Dermatology Life Quality Index (DLQI)
|
-13.4 units on a scale
Standard Error 1.56
|
-14.3 units on a scale
Standard Error 1.59
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants.
The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction
Outcome measures
| Measure |
Ixekizumab Q2W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
|
Ixekizumab Q4W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
|
|---|---|---|
|
Mean Change From Baseline in Percent Body Surface Area (%BSA)
|
-26.1 percentage of body surface area
Standard Error 1.39
|
-28.0 percentage of body surface area
Standard Error 1.39
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants.
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in PASI scores compared to baseline. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction.
Outcome measures
| Measure |
Ixekizumab Q2W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
|
Ixekizumab Q4W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
|
|---|---|---|
|
Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI)
|
-22.00 units on a scale
Standard Error 0.456
|
-22.72 units on a scale
Standard Error 0.456
|
SECONDARY outcome
Timeframe: Baseline though Week 12Population: All randomized participants.
The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 NRS the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.
Outcome measures
| Measure |
Ixekizumab Q2W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
|
Ixekizumab Q4W
n=6 Participants
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
|
|---|---|---|
|
Time to at Least a 2 Point Improvement on the PatGA Score
|
10.0 Days
Interval 6.0 to 12.0
|
13.5 Days
Interval 5.0 to 22.0
|
Adverse Events
Ixekizumab Q2W Induction Dosing Period
Ixekizumab Q4W Induction Dosing Period
Ixekizumab 80 mg Q4W Maintenance
Ixekizumab 80 mg Q4W Post-treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ixekizumab Q2W Induction Dosing Period
n=6 participants at risk
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
|
Ixekizumab Q4W Induction Dosing Period
n=6 participants at risk
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
|
Ixekizumab 80 mg Q4W Maintenance
n=12 participants at risk
After week 12 all participants are given 80 mg ixekizumab as a single SC injection once Q4W through week 44.
|
Ixekizumab 80 mg Q4W Post-treatment
n=12 participants at risk
All participants receiving at least one dose of ixekizumab entered the post treatment follow-up period for a minimum of 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Fatigue
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Injection site erythema
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
8.3%
1/12 • Number of events 3
|
0.00%
0/12
|
|
General disorders
Injection site urticaria
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
|
Infections and infestations
Influenza
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
|
Infections and infestations
Localised infection
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
33.3%
4/12 • Number of events 4
|
0.00%
0/12
|
|
Investigations
Biopsy breast
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
|
Investigations
Biopsy prostate
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
|
Surgical and medical procedures
Eye laser surgery
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60